System, Radiation Therapy, Charged-particle, Medical

IBA Dosimetry GmbH

The following data is part of a premarket notification filed by Iba Dosimetry Gmbh with the FDA for Myqa Ion.

Pre-market Notification Details

Device IDK201798
510k NumberK201798
Device Name:MyQA ION
ClassificationSystem, Radiation Therapy, Charged-particle, Medical
Applicant IBA Dosimetry GmbH Bahnhofstrasse 5 Schwarzenbruck,  DE D-90592
ContactAndreas Suchi
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeLHN  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-06-30
Decision Date2020-07-17

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